Prevention of Functional and Cognitive Impairment in Hospitalized Oncogeriatric Patients

Not Applicable

Completed

• Conditions: Aging; Cancer; Hospital Acquired Condition; Debility
• Interventions: Behavioral: Multicomponent exercise

• Registration Number: NCT05424055
• Lead Sponsor: Fundacion Miguel Servet

Brief Summary

Hospitalized older patients usually remain bedridden for many hours and this may lead to the appearance of unwanted negative consequences, such as cognitive or physical decline upon discharge. Our study will analyze whether an intervention consisting of a multicomponent training programme applied to patients over the age of 60 who are hospitalized for acute medical conditions in an Oncology Department of a tertiary hospital improves functional capacity and cognitive function. A total of 50 hospitalized older adult patients will be recruited in the Hospital Universitario de Navarra, Pamplona, Spain. The participants will be randomized and included in an exercise intervention (n = 25) or a control (n = 25) group (hospital usual-care). The intervention consists of a multicomponent exercise training programme that will take place for 3 consecutive days (2 sessions/day). The control group will receive usual hospital care, which will include physical rehabilitation when needed. Functional and cognitive impairment after and during acute hospitalization in older adults are major determinants of the later need for health resources. If our hypothesis is correct and shows that a multicomponent, individualized and progressive exercise programme is an effective therapy for improving the functional capacity of acutely hospitalized older patients compared to usual care, a change in the current system of hospitalization may be justified in oncogeriatric patients with medical conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Primary Completion: 2024-03-21
• Study Completion: 2024-03-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Age > 65 years
• Barthel Index ≥60 points
• Able to ambulate (with/without assistance)
• Sign the informed consent
• Able to communicate

Exclusion Criteria

• Expected length of stay < 6 days
• Terminal illness
• Very severe cognitive decline (i.e., GDS 7)
• Uncontrolled arrhythmias, acute pulmonary embolism, acute myocardial infarction or limb bone fracture in the past 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multicomponent Exercise	Multicomponent exercise	The intervention will consist of a multicomponent exercise training programme, which will include supervised progressive resistance exercise training, balance training, and walking for 3 consecutive days. During the training period, patients will be trained in 20-minute sessions twice a day (morning and evening).

Primary Outcome Measures

Name	Time	Method
Change in cognitive function: Minimental State Evaluation (MMSE; Spanish version)	12 months	The change in MMSE will be measured at baseline and follow-up. Minimum 1 Maximum 35 Higher scores mean a better outcome
Change in functional capacity: Short Physical Performance Battery test (SPPB; Spanish versión)	12 months	The change in SPPB measured at baseline and follow-up (a measure of balance, gait, and rising from a chair) Minimum 1 Maximum 12 Higher scores mean a better outcome

Secondary Outcome Measures

Name	Time	Method
Change in functional capacity: Barthel Index (spanish version)	12 months	The change in Barthel Index measured at baseline and follow-up (a measure of Basic Activities of Daily Living) Minimum 0 Maximum 100 Higher scores mean a better outcome
Changes in mood status: the 15-item Yesavage Geriatric Depression Scale (GDS-VE), Spanish version	12 months	The change in Yesavage Geriatric Depression Scale measured at baseline and follow-up
Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire	12 months	The change in EuroQol-5 Dimension (EQ-5D) questionnaire, measured at baseline and follow-up.; The EQ records the respondent's overall current health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' Minimum 0 Maximum 100 Higher scores mean a better outcome
Changes in handgrip strength (dominant hand)	12 months	The change in handgrip strength at baseline and follow-up
Gait ability will be assessed using the 6-metre gait velocity test (GVT)	12 months	The change in gait velocity test measured at baseline and follow-up
Changes in the Trail Making Test (TMT) part A	12 months	The change in Trail Making Test measured at baseline and follow-up. Minimum 0 Results are reported as the number of seconds required to complete the task; higher scores reveal greater impairment.
Dual task GVT (verbal GVT and arithmetic GVT)	12 months	The change in Dual task measured at baseline and follow-up. During the verbal dual-task test the investigarors will measure the gait velocity while participants name animals aloud. The cognitive score wil be measured by counting the number of animals named (verbal dual task) or by counting the numbers that were stated (arithmetic dual task) and the errors in each task. Minimum 0 Higher scores reveal greater impairment.

Trial Locations

Locations (1)

Hospital Universitario de Navarra; 🇪🇸 Pamplona, Navarra, Spain